Cleared Special

X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE

K042466 · Zest Anchors, Inc. · Dental

Nov 2004

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K042466 is an FDA 510(k) clearance for the X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Zest Anchors, Inc. (Escondido, US). The FDA issued a Cleared decision on November 24, 2004, 72 days after receiving the submission on September 13, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K042466 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2004
Decision Date	November 24, 2004
Days to Decision	72 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Statement

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.